Dose Confirmation Efficacy Study (V260-007)

September 11, 2015 updated by: Merck Sharp & Dohme LLC

Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The duration of treatment is 10 months.

Study Type

Interventional

Enrollment (Actual)

1312

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy infants

Exclusion Criteria:

  • History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
  • Known or suspected problems with immune system
  • Fever at time of immunization
  • Prior administration of a rotavirus vaccine
  • History of known prior rotavirus disease
  • Chronic diarrhea, or failure to thrive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent)

administered 28 to 70 days apart.
Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent
Three doses of RotaTeq™ administered 28 to 70 days apart.
Other Names:
  • V260
Placebo Comparator: Placebo matching RotaTeq™
Placebo matching RotaTeq™ administered 28 to 70 days apart.
Biological: Comparator: Placebo matching RotaTeq™
Placebo matching RotaTeq™ administered 28 to 70 days apart.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
Time Frame: At least 14 days following the 3rd vaccination
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
At least 14 days following the 3rd vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With ≥3 Fold Rise in Antibody Titer
Time Frame: 14 days following the 3rd vaccination
Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)
14 days following the 3rd vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

September 22, 2004

First Submitted That Met QC Criteria

September 24, 2004

First Posted (Estimate)

September 27, 2004

Study Record Updates

Last Update Posted (Estimate)

September 14, 2015

Last Update Submitted That Met QC Criteria

September 11, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V260-007
  • 2004_077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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